Medical Device Manufacturer · US , Boston , MA

Etiometry, Inc. - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 2015

Recent clearances: Etiometry Platform, Etiometry Platform (DAV 5.4 RAE 9.2), T3 Platform software

Official Website
11
Total
11
Cleared
0
Denied

FDA 510(k) Regulatory Record - Etiometry, Inc. Cardiovascular ✕

11 devices
1-11 of 11
Cleared Apr 03, 2026
Etiometry Platform
K254066 · PPW
Cardiovascular · 106d
Cleared Feb 12, 2025
Etiometry Platform (DAV 5.4 RAE 9.2)
K241479 · PPW
Cardiovascular · 264d
Cleared Jul 07, 2023
T3 Platform software
K223578 · PPW
Cardiovascular · 219d
Cleared Jan 06, 2023
T3 Platform software
K213423 · PLB
Cardiovascular · 443d
Cleared Jun 22, 2022
T3 Platform Software
K213230 · PPW
Cardiovascular · 266d
Cleared Nov 25, 2020
T3 Platform software
K202306 · MWI
Cardiovascular · 103d
Cleared Dec 08, 2019
T3 Platform software
K190273 · MWI
Cardiovascular · 303d
Cleared May 26, 2017
T3 Software
K163065 · MWI
Cardiovascular · 205d
Cleared Mar 31, 2016
T3 Software
K152258 · PLB
Cardiovascular · 233d
Cleared Oct 29, 2015
T3 Software
K151715 · MWI
Cardiovascular · 126d
Cleared Mar 04, 2015
T3 Software
K142732 · MWI
Cardiovascular · 162d
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